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Experts for making pharmacovigilance mandatory in CDA Bill

Ramesh Shankar, Mumbai
Monday, December 16, 2013, 08:00 Hrs  [IST]

Experts in the industry have recommended to the parliamentary standing committee on health and family welfare that examines the Central Drugs Administration (CDA) Bill to make pharmacovigilance mandatory in the proposed CDA Bill for continuous monitoring of adverse drug reactions (ADRs).

Presently, the parliamentary standing committee headed by Brajesh Pathak is examining the Drugs and Cosmetics (Amendment) Bill, 2013 that seeks to establish the CDA. The bill seeks to centralise licensing in 17 categories of very critical drugs included in the proposed Third Schedule of the Act.

“Requirement of post marketing (phase IV) trial to assess safety of new drugs in post marketing scenario should be an ongoing exercise. Pharmacovigilance system implemented by the government should be integrated with safety management activities required to be performed by the regulatory authority. Pharmacovigilance for continuous monitoring of ADRs must be made mandatory,” recommended PD Sheth, an expert in the industry.

In his submission to the committee, Sheth recommended that validated pharmacovigilance database having functionalities of signal detection, analysis, assessment and recommendation of actions should be developed. In addition to this, trained staff to monitor, assess and recommend actions on the safety information as per international standards is required.

The website of the CDA should have a redressal mechanism to receive complaints from patients and prescribers regarding their adverse experiences with various interventions such as drugs, medical devices and biological etc and the same could be recorded in the central database maintained by office of the DCGI for the purpose of pharmacovigilance management and used for updating both Indian Pharmacopoeia and National Formulary of India, Sheth, who is the vice-president, International Pharmaceutical Federation, The Hague, recommended to the committee.

Apart from this, Sheth, who is also the past president of Indian Pharmaceutical Association (IPA), recommended to the committee that one person nominated by the IPA from amongst its members should be included in the Drug Technical Advisory Board (DTAB).


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